CN103585515A - Effervescing agent medicament for treating children alimentary anemia - Google Patents

Effervescing agent medicament for treating children alimentary anemia Download PDF

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CN103585515A
CN103585515A CN201310502737.9A CN201310502737A CN103585515A CN 103585515 A CN103585515 A CN 103585515A CN 201310502737 A CN201310502737 A CN 201310502737A CN 103585515 A CN103585515 A CN 103585515A
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孙霞
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Qingdao Huaren Technology Incubator Co Ltd
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Abstract

The invention provides an effervescing agent medicament for treating children alimentary anemia. The effervescing agent medicament comprises the following traditional Chinese medicine composition as a main effervescing agent material and an auxiliary effervescing agent material in parts by weight: 200-300 parts of the main effervescing agent material and 50-400 parts of the auxiliary effervescing agent material. The effervescing agent medicament is good in curative effect, rapid to take effect, capable of treating children alimentary anemia well, and has multiple advantages in improving symptom, prompting iron element absorption and reducing side effects when being compared with the conventional ferrous sulfate.

Description

Be used for the treatment of the nourish one's nature effervescent medicine of anemia of juvenile camp
Technical field
The present invention relates to medical preparing technical field, relate in particular to a kind of juvenile camp's effervescent medicine of anemia and preparation method thereof of nourishing one's nature that is used for the treatment of.
Background technology
Nutritional anemia is a kind of microcytic hypochromic anemia, by iron deficiency in body, cause the synthetic institute that reduces of hemoglobin to cause, clinical in serum iron, transferrins saturation and Decrease of Serum Ferritin Level, adopting iron in treatment is effectively feature, and cardinal symptom has that pale or sallow complexion, lip and nail color are light, fatigue and weakness, inappetence etc.The world approximately has 10~30% crowd to have iron deficiency in various degree, and especially infant sickness rate is higher.It not only affects children's upgrowth and development and multiple organ injury, sluggishness to child intelligence infringement in potential long term and motor development is usually irreversible, be also simultaneously cause cellular immunization, humoral immune function is impaired and often cause and infect and the major reason of health level decline.
Gently, the nutritional anemia of moderate, general prognosis is better; Anemia or long-term light anemia, or cause visceral dysfunction, affect children ' s healthy growth, or because of insufficiency of vital energy and blood, a little less than causing the imperial evil power of child, be easy to being invaded by exogenous pathogen.
Nutritional anemia is department of pediatrics common disease, mainly occurs in the infant of 6 months to 3 years old.Although due to the improvement of global economy development and nutrition health condition, various food deficiency diseases all obviously reduce, nutritional anemia is still the common food deficiency disease that threatens child health, not only in developing country, even in developed country, also belongs to commonly encountered diseases.Does World Health Organization (WHO) (WHO) the report whole world reach 40 in sideropenic population? 5000000000, account for 66%~80% of total population; Nearly 2,000,000,000 people, surpass 30% of total population and suffer from anemia, and wherein great majority face the threat of iron deficiency anemia.According to another World Health Organization (WHO) (WHO) and United Nations Children's Fund (UNICEF), report that it is 20.1% that 5 years old following incidence rate of children anaemia was reaches 39.0% , developed country in undeveloped country.
Nutritional anemia all has considerable influence, serious harm child health to the intelligence of infant, anthropometic, immunologic function, digestive and absorptive functions, nervous system etc.China's Ministry of Public Health is classified primary disease as one of department of pediatrics four diseases of national keypoint control.
Modern medicine thinks that primary disease is to lack the ferrum that can dye in the organ-tissues such as bone marrow, liver, spleen, serum iron, transferrins saturation and Decrease of Serum Ferritin Level, take that microcytic hypochromic anemia, serum ferritin reduce and iron in treatment is effectively feature clinically.
Modern medicine thinks that iron metabolism index and iron deficiency anemia pathogeny have close relationship, the particularly research to indexs such as serum \ ferrum, ferritin, transferrins and total iron binding capacitys, think and can make serum levels of iron, ferritin raise and serum transferrin, total iron binding capacity are reduced in the process of recovering at Irondeficiencyanemia, and also similar variation can be there is in doctor trained in Western medicine iron in treatment.
After dispelling the Basic disease cause that causes iron deficiency anemia, western medicine is mainly that to supplement ferrum element be main, after the people such as Castle in 1932 studies have shown that inorganic iron is hemoglobin (Hb) raw material, oral ferrous sulfate is in the world always as the main means of controlling iron deficiency.Through clinical trial proof chalybeate, be the specific drug for the treatment of iron deficiency anemia, its kind is a lot, with oral inorganic salt, is generally most economical, convenient and effective method.Ferrous iron than the easy absorption of ferric iron, therefore adopt more.Conventional have a ferrous sulfate, and iron-holder is 20%; Ferrous fumarate, iron content 30%.For baby's taking convenience, polygamy becomes 2.5% mixture of ferrous sulfate solution.
Although traditional iron supplement method is effective, but long-term practice also proves, the long shortcoming that the course for the treatment of, iron supplement existed some to be difficult for overcoming of this larger dose: can cause the side effect such as infantile diarrhea, loss of appetite, so infant is usually because gastrointestinal side effect can not tolerate and stopped treatment.Prolonged application iron in treatment, can cause that iron bioavailability is low, the gastrointestinal reaction shortcoming such as heavily, and its application is clinically subject to certain restrictions.
In traditional Chinese medical science ancient literature, this name of disease of not nutritious property anemia is recorded.According to Symptoms, modern scholar thinks: nutritional anemia belongs to " blood deficiency ", " asthenia ", " the skin ulcer card " of Chinese medicine, the category of " general edema with yellowish skin is sick ".Chinese medicine preparation is better than Oral Iron Preparations improving aspect symptom, and gastrointestinal function is improved to effect; After drug withdrawal, be difficult for recurrence, this points out us to utilize tcm syndrome differentiation and treatment, brings into play the characteristic of the traditional Chinese medical science to improve clinical efficacy, and can bring into play the advantage of traditional Chinese medical science preventive treatment of disease.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of nourish one's nature Chinese medicine effervescent of anemia of juvenile camp that is used for the treatment of, its good effect, instant effect, can be good at treating juvenile camp's anemia of nourishing one's nature, compare with traditional ferrous sulfate, improving symptom, promote ferrum element to absorb, reduce aspect side effect to have more advantage.
For solving the problems of the technologies described above, the invention provides a kind of nourish one's nature Chinese medicine effervescent of anemia of juvenile camp that is used for the treatment of, it comprises that Chinese medicine composition is as effervescent major ingredient and effervescent adjuvant, the weight portion of effervescent major ingredient and effervescent adjuvant is respectively effervescent major ingredient 200 weight portion~300 weight portions, effervescent adjuvant 50 weight portion~400 weight portions.
Wherein, the crude drug component of described Chinese medicine composition comprises: Radix Ginseng, the Radix Astragali, Radix seu Herba Gei aleppici, Semen Coicis, the Rhizoma Atractylodis Macrocephalae, Herba Lysimachiae, Herba Ecliptae, Caulis Spatholobi, Radix Polygoni Multiflori, Radix Inulae, the Radix Paeoniae Alba, Radix Et Caulis Acanthopanacis Senticosi, Semen Raphani, Fructus Mori, Colla cornus cervi, Radix Salviae Miltiorrhizae, Herba Verbenae, Arillus Longan, Radix Rehmanniae Preparata, Caulis Gneti, Fructus Choerospondiatis, Semen Juglandis and pulvis ferri (ferrosic oxide).
Wherein, in described Chinese medicine, the weight of each crude drug is respectively that people joins 60 weight portion~70 weight portions, the Radix Astragali 50 weight portion~60 weight portions, Radix seu Herba Gei aleppici 45 weight portion~55 weight portions, Semen Coicis 30 weight portion~40 weight portions, the Rhizoma Atractylodis Macrocephalae 30 weight portion~40 weight portions, Herba Lysimachiae 20 weight portion~30 weight portions, Herba Ecliptae 35 weight portion~45 weight portions, Caulis Spatholobi 80 weight portion~90 weight portions, Radix Polygoni Multiflori 60 weight portion~70 weight portions, Radix Inulae 25 weight portion~35 weight portions, the Radix Paeoniae Alba 50 weight portion~60 weight portions, Radix Et Caulis Acanthopanacis Senticosi 30 weight portion~40 weight portions, Semen Raphani 25 weight portion~35 weight portions, Fructus Mori 60 weight portion~70 weight portions, Colla cornus cervi 70 weight portion~80 weight portions, Radix Salviae Miltiorrhizae 30 weight portion~40 weight portions, Herba Verbenae 30 weight portion~40 weight portions, Arillus Longan 30 weight portion~40 weight portions, Radix Rehmanniae Preparata 90 weight portion~100 weight portions, Caulis Gneti 30 weight portion~40 weight portions, Fructus Choerospondiatis 35 weight portion~45 weight portions, Semen Juglandis 60 weight portion~70 weight portions, pulvis ferri (ferrosic oxide) 45 weight portion~55 weight portions.
Wherein, in described Chinese medicine composition, the weight of each crude drug is respectively that people joins 65 weight portions, the Radix Astragali 55 weight portions, Radix seu Herba Gei aleppici 50 weight portions, Semen Coicis 35 weight portions, the Rhizoma Atractylodis Macrocephalae 35 weight portions, Herba Lysimachiae 25 weight portions, Herba Ecliptae 40 weight portions, Caulis Spatholobi 85 weight portions, Radix Polygoni Multiflori 65 weight portions, Radix Inulae 30 weight portions, the Radix Paeoniae Alba 55 weight portions, Radix Et Caulis Acanthopanacis Senticosi 35 weight portions, Semen Raphani 30 weight portions, Fructus Mori 65 weight portions, Colla cornus cervi 75 weight portions, Radix Salviae Miltiorrhizae 35 weight portions, Herba Verbenae 35 weight portions, Arillus Longan 35 weight portions, Radix Rehmanniae Preparata 95 weight portions, Caulis Gneti 35 weight portions, Fructus Choerospondiatis 40 weight portions, Semen Juglandis 65 weight portions, pulvis ferri (ferrosic oxide) 50 weight portions.
Wherein, described effervescent adjuvant comprises carbon dioxide source, acid source, disintegrating agent and filler.
Wherein, disintegrating agent in effervescent adjuvant: acid source: the ratio of the weight of carbon dioxide source is 0.5~0.8: 0.4~0.6: 0.3~0.6: 0.4~0.6.
The present invention also provides the preparation method of above-mentioned Chinese medicine effervescent, is specially:
The first step, the extraction of described Chinese medicine composition;
Second step, the purification of the extract that the first step obtains;
The 3rd step, by the extract after second step purification and effervescent adjuvant mixing granulation, tabletting, obtains effervescent tablet.
Wherein, the described first step is specially mixes each raw material medicaments in part by weight in described Chinese medicine composition, stir, add the water with respect to 6~8 times of mixture qualities, it is 2~3 that the hydrochloric acid that is 5% by volumetric concentration regulates the pH value of water, soak 1 hour~2 hours, decoct subsequently 3 hours~5 hours, decoction liquor is filtered, filtering residue adds the water with respect to 4~6 times of mixture qualities again, decoct 3 hours~5 hours, decoction liquor is filtered, decoction liquor is merged, by mass percentage concentration, be that 10% sodium hydroxide regulates pH value to 6~7, obtain extracting solution, the mastic that at 50 ℃ of extracting solution simmer down tos, relative density is 1.10~1.20, be cooled to room temperature, adding concentration is that 95% ethanol to alcohol content reaches 60%, 0 ℃ of cold preservation 12 hours, filter, filtrate decompression concentration and recovery ethanol, be concentrated into the mastic that at 50 ℃, relative density is 1.10~1.20.
Wherein, described second step is specially the thick paste that the first step is obtained and adds on the macroporous adsorptive resins of D101 type, first adopt the water of 1~2 times of column volume to rinse, adopting 3~5 times of ethanol elutions that column volume determining alcohol is 30%, adopt again the ethanol elution that 3~5 times of column volume determining alcohols are 70%, the ethanol elution that the ethanol elution that collection determining alcohol is 30% and determining alcohol are 70%, being evaporated to relative density at 50 ℃ is 1.10~1.20, add isopyknic water, 0 ℃ of cold preservation 12 hours, filter, filtrate is concentrated except desolventizing, pulverize, dry, obtain Chinese medicine composition and extract purified.
The present invention also provides a kind of nourish one's nature crude drug component of Chinese medicine composition of anemia of juvenile camp that is used for the treatment of to comprise: Radix Ginseng, the Radix Astragali, Radix seu Herba Gei aleppici, Semen Coicis, the Rhizoma Atractylodis Macrocephalae, Herba Lysimachiae, Herba Ecliptae, Caulis Spatholobi, Radix Polygoni Multiflori, Radix Inulae, the Radix Paeoniae Alba, Radix Et Caulis Acanthopanacis Senticosi, Semen Raphani, Fructus Mori, Colla cornus cervi, Radix Salviae Miltiorrhizae, Herba Verbenae, Arillus Longan, Radix Rehmanniae Preparata, Caulis Gneti, Fructus Choerospondiatis, Semen Juglandis and pulvis ferri (ferrosic oxide).
Beneficial effect of the present invention:
Chinese medicine effervescent provided by the invention, its good effect, instant effect, can be good at treating juvenile camp's anemia of nourishing one's nature, and compares, improving symptom, promote to absorb, reduce aspect side effect and have more advantage with traditional ferrous sulfate.
The specific embodiment
Theory of Chinese medical science think the generation of primary disease and children's congenital examine compose not enough, the day after tomorrow improper feeding, or it is relevant to infect parasites, disease injury etc., sick position is mainly in spleen, kidney, conscience, blood deficiency is not flourish is its pathologic basis; The relation of the generation of blood and spleen kidney is the closest." blood person, essence of water and grain is born in spleen ", " spleen is source of generating QI and blood ".Taste are received digesting food, produce cereal nutrient, for the generation of blood provides Material Source.
The root of kidney asthenia as the principal aspect disease, kidney storing essence, the raw marrow of main bone, essence can be changed blood, marrow energy hemopoietic, essence and blood sharing the same origin, suffers from a deficiency of the kidney that essence and blood source is not enough, and temper depends on the warm of yang-energy of kidney can the precise and tiny blood that is changed to of normal metaplastic, and the marrow virtual loss of suffering from a deficiency of the kidney blood must be empty few.Kidney is that whole body vigour is basic, kidney storing essence, and raw marrow, main bone, therefore kidney essense is abundant, can changes and be blood.Modern study thinks that traditional Chinese medical science invigorating kidney, promoting blood circulation can regulate body's immunity, stimulates hemopoietic function of bone marrow, improves bone marrow microenvironment, make hemoglobin reduction no matter the removal of the cause of disease still regenerate and recover all to play an important role.Modern medicine is thought the organ that bone marrow, liver, spleen etc. are storage ferrum, and ferrum is the main component of synthetic hemoglobin, thinks kidney controlling essence storage with the traditional Chinese medical science, the raw marrow of main bone, and marrow hemopoietic has points of resemblance.
Taste are the key of primary disease, and spleen and kidney are the relation of " day after tomorrow " and " congenital ", are mutual promotions, mutually promote, on pathology, also influence each other, and reciprocal causation.Insufficiency of kidney-YANG can not be warm spleen sun; A little less than deficiency of spleen-YANG, the precise and tiny kidney yang of inability of food and drink to be digested and transported is lost it and is supplemented nutrition." qi being the governor of blood, blood being the material foundation of QI ", gas and blood have contact closely between the two.Qi promoting blood production, refers in the composition and generative process thereof of blood, all be unable to do without gentle motion change one gasification function of gas.Ying-qi and body fluid, be the key component of blood, and they are from the essence of water and grain of taste institute transporting.From the ingesta of taking in, change into essence of water and grain, then change into ying-qi and body fluid, then change into blood, all be unable to do without the motion change of gas.Spleen invigorating can supplement the deficiency of taste, for QI and blood biochemistry provides home, and the QI invigorating hemopoietic of can invigorating blood circulation.The generation of blood and the relation of spleen are the closest." blood person essence of water and grain is born in spleen ", " spleen is source of generating QI and blood ".Taste are received digesting food, produce cereal nutrient, and for the generation of blood provides Material Source, the raw function of change of spleen is the power that blood generates.Temper also has the function of having the normal operation of blood under one's command.The many reasons such as eating and drinking without temperance, overstrain, weakness due to chronic disease all can undermine spleen and stomach function, cause water paddy and are received deficiency, cause the weary source of cereal nutrient, or occur the raw miopragia of spleenization, the precise and tiny obstacle that utilizes, thus cause primary disease to occur.Deficiency-weakness of spleen-QI, has dereliction of duty under one's command, and outside blood oozing from the body openings or subcuta neous tissue arteries and veins, Massive Bleeding (acute or chronic) also can cause primary disease.
" qi being the governor of blood, blood being the material foundation of QI ", gas and blood have contact closely between the two.Qi promoting blood production, refers in the composition and generative process thereof of blood, all be unable to do without gentle motion change one gasification function of gas.Ying-qi and body fluid, be the key component of blood, and they are from the essence of water and grain of taste institute transporting.From the ingesta of taking in, change into essence of water and grain, then change into ying-qi and body fluid, then change into blood, all be unable to do without the motion change of gas.Therefore say qi promoting blood production.Gas is prosperous, and the function of changing hemopoietic liquid is also strong; The deficiency of vital energy, the function of changing hemopoietic liquid also a little less than, very can cause blood deficiency.
Iron deficiency anemia is the physical result that factors causes, nutrient blood loss, the internal organs of the five internal organs all lose its support and be infested with all diseases, wherein a crucial factor is weakness of the spleen and stomach, receive and transport mistake department, the biochemical weary source of QI and blood, and cause anemia, therefore, under the prompting of this Chinese traditional treatment theory, though we enrich blood and invigorate blood circulation as Therapeutic Principle with invigorating the spleen and benefiting QI, although the too late directly iron supplement of the degree of its iron supplement and speed, but under the state of low ferrum, but can significantly improve the bioavailability of ferrum.
Based on this, the nourish one's nature crude drug component of Chinese medicine composition of anemia of juvenile camp that is used for the treatment of provided by the invention comprises: Radix Ginseng, the Radix Astragali, Radix seu Herba Gei aleppici, Semen Coicis, the Rhizoma Atractylodis Macrocephalae, Herba Lysimachiae, Herba Ecliptae, Caulis Spatholobi, Radix Polygoni Multiflori, Radix Inulae, the Radix Paeoniae Alba, Radix Et Caulis Acanthopanacis Senticosi, Semen Raphani, Fructus Mori, Colla cornus cervi, Radix Salviae Miltiorrhizae, Herba Verbenae, Arillus Longan, Radix Rehmanniae Preparata, Caulis Gneti, Fructus Choerospondiatis, Semen Juglandis and pulvis ferri (ferrosic oxide).
Further preferably, described Chinese medicine only consists of above-mentioned raw materials medicine.
In side, Radix Ginseng strongly invigorating primordial QI, invigorating the spleen to benefit the lung, hemopoietic function of bone marrow is had to protection stimulation, can make the blood cell count of anemia animal, hemoglobin and platelet increase, Radix Astragali tonifying Qi and lifting yang, benefit is defended solid, two medicines share invigorating the spleen and benefiting QI, can promote Hemopoietic factor to produce, Radix seu Herba Gei aleppici air making-up and spleen enlivening, dampness diuretic, strengthening superficial resistance to stop perspiration, Semen Coicis, Herba Lysimachiae promoting diuresis to eliminate damp pathogen, spleen-benefiting mind-tranquilizing, strengthen the merit of spleen invigorating QI invigorating, Herba Ecliptae, the Radix Paeoniae Alba, Caulis Spatholobi nourishing YIN and benefiting blood is invigorated blood circulation, can increase Peripheral Erythrocytes, leukocyte and hemoglobin number, to pluripotent stem cell, the quantity of grain system and erythroid cells is all significantly increased, Radix Polygoni Multiflori can the hemopoietic factor be secreted, can promote the synthetic of erythrocytic growth promoter and hemoglobin, the gas reason of waking up spleen, in Radix Inulae, contained volatile oil has gentle stimulation to gastrointestinal tract, can the secretion of facilitating digestion liquid and eliminating enteral pneumatosis.Radix Inulae and benefiting qi and nourishing blood medicine compatibility, invigorating middle warmer has fortune, make it benefit and do not hinder stomach, tonify without causing stagnation, Radix Et Caulis Acanthopanacis Senticosi liver and kidney tonifying, benefit intensive culture blood, Semen Raphani stomach invigorating and in, relieving dyspepsia effect, can be aid digestion, appetite stimulator, Fructus Mori nourishing the liver is enriched blood, contain vitamin C, ferrum etc., can increase gastric enzyme, promote the absorption of ferrum, in Colla cornus cervi, contain a large amount of chalybeates and trace element, vitamin, can promote erythrocytic generation, Radix Salviae Miltiorrhizae can be accelerated blood flow by blood vessel dilating, improve microcirculation, change viscosity of blood and blood circulation promoting and blood stasis dispelling, eliminating blood stasis to promote regeneration of blood, Herba Verbenae promoting blood circulation to remove blood stasis, removing toxic substances diuretic, Arillus Longan the kidney invigorating and essence nourishing, benefiting QI and nourishing blood, the Rhizoma Atractylodis Macrocephalae can increase the secretion of digestive system, hemopoietic system, rising erythrocyte and hemoglobin, improve lymhocyte transformation rate, Radix Rehmanniae Preparata can hemopoietic system, rising erythrocyte, Caulis Gneti expelling wind and removing dampness, eliminating stasis to stop pain, Fructus Choerospondiatis promoting flow of QI and blood, tranquilizing by nourishing the heart, Semen Juglandis the kidney invigorating and essence nourishing, warming the lung Dingchuan, pulvis ferri (ferrosic oxide) iron supplement is enriched blood, the all medicines of Chinese medicine provided by the invention share Co stituation hemopoietic system, promote hemopoietic progenitor cell of red blood cell line growth, erythrocyte and hemoglobin are raise, energy adjusting joint patient physiological function, invigorating the spleen and regulating the stomach, promote digesting and assimilating of ferrum and nutritional labeling, make to treat the effect lasting stability of anemia.
In described Chinese medicine composition, the weight of each crude drug is respectively: Radix Ginseng 60 weight portion~70 weight portions, the Radix Astragali 50 weight portion~60 weight portions, Radix seu Herba Gei aleppici 45 weight portion~55 weight portions, Semen Coicis 30 weight portion~40 weight portions, the Rhizoma Atractylodis Macrocephalae 30 weight portion~40 weight portions, Herba Lysimachiae 20 weight portion~30 weight portions, Herba Ecliptae 35 weight portion~45 weight portions, Caulis Spatholobi 80 weight portion~90 weight portions, Radix Polygoni Multiflori 60 weight portion~70 weight portions, Radix Inulae 25 weight portion~35 weight portions, the Radix Paeoniae Alba 50 weight portion~60 weight portions, Radix Et Caulis Acanthopanacis Senticosi 30 weight portion~40 weight portions, Semen Raphani 25 weight portion~35 weight portions, Fructus Mori 60 weight portion~70 weight portions, Colla cornus cervi 70 weight portion~80 weight portions, Radix Salviae Miltiorrhizae 30 weight portion~40 weight portions, Herba Verbenae 30 weight portion~40 weight portions, Arillus Longan 30 weight portion~40 weight portions, Radix Rehmanniae Preparata 90 weight portion~100 weight portions, Caulis Gneti 30 weight portion~40 weight portions, Fructus Choerospondiatis 35 weight portion~45 weight portions, Semen Juglandis 60 weight portion~70 weight portions, pulvis ferri (ferrosic oxide) 45 weight portion~55 weight portions.
Further preferably, in described Chinese medicine composition, the weight of each crude drug is respectively that people joins 65 weight portion~70 weight portions, the Radix Astragali 55 weight portion~60 weight portions, Radix seu Herba Gei aleppici 50 weight portion~55 weight portions, Semen Coicis 30 weight portion~35 weight portions, the Rhizoma Atractylodis Macrocephalae 35 weight portion~40 weight portions, Herba Lysimachiae 20 weight portion~25 weight portions, Herba Ecliptae 35 weight portion~40 weight portions, Caulis Spatholobi 85 weight portion~90 weight portions, Radix Polygoni Multiflori 65 weight portion~70 weight portions, Radix Inulae 25 weight portion~30 weight portions, the Radix Paeoniae Alba 55 weight portion~60 weight portions, Radix Et Caulis Acanthopanacis Senticosi 30 weight portion~35 weight portions, Semen Raphani 25 weight portion~30 weight portions, Fructus Mori 65 weight portion~70 weight portions, Colla cornus cervi 75 weight portion~80 weight portions, Radix Salviae Miltiorrhizae 35 weight portion~40 weight portions, Herba Verbenae 30 weight portion~35 weight portions, Arillus Longan 35 weight portion~40 weight portions, Radix Rehmanniae Preparata 95 weight portion~100 weight portions, Caulis Gneti 30 weight portion~35 weight portions, Fructus Choerospondiatis 35 weight portion~40 weight portions, Semen Juglandis 65 weight portion~70 weight portions, pulvis ferri (ferrosic oxide) 50 weight portion~55 weight portions.
Most preferably, in described Chinese medicine composition, the weight of each crude drug is respectively that people joins 65 weight portions, the Radix Astragali 55 weight portions, Radix seu Herba Gei aleppici 50 weight portions, Semen Coicis 35 weight portions, the Rhizoma Atractylodis Macrocephalae 35 weight portions, Herba Lysimachiae 25 weight portions, Herba Ecliptae 40 weight portions, Caulis Spatholobi 85 weight portions, Radix Polygoni Multiflori 65 weight portions, Radix Inulae 30 weight portions, the Radix Paeoniae Alba 55 weight portions, Radix Et Caulis Acanthopanacis Senticosi 35 weight portions, Semen Raphani 30 weight portions, Fructus Mori 65 weight portions, Colla cornus cervi 75 weight portions, Radix Salviae Miltiorrhizae 35 weight portions, Herba Verbenae 35 weight portions, Arillus Longan 35 weight portions, Radix Rehmanniae Preparata 95 weight portions, Caulis Gneti 35 weight portions, Fructus Choerospondiatis 40 weight portions, Semen Juglandis 65 weight portions, pulvis ferri (ferrosic oxide) 50 weight portions.
In described Chinese medicine composition, the pharmacology of each crude drug is as follows:
Radix Ginseng: sweet in the mouth, micro-hardship, slightly warm in nature, enter the heart, lung, spleen channel, have strongly invigorating primordial QI, using tonifying Qi reinforcing lungs, promoting the production of body fluid to quench thirst, the effects such as Fructus Alpiniae Oxyphyllae of calming the nerves, both for emergency treatment of collapse is held up good dose of danger, also for treating the first key medicine of asthenia internal injury, the card of all insufficiency of vital energy and bloods all can be applied, cure mainly that impairment caused by overstrain is deficient, lack of appetite, asthenia, regurgitation are told food, stool lingering diarrhea, empty cough with asthma are short, spontaneous perspiration sudden collapse, palpitation with fear, forgetful, dizziness and headache, sexual impotence, frequent micturition, quench one's thirst, woman uterine bleeding, children's's intermittent infantile convulsion and the card such as prolonged deficiency is multiple.
The Radix Astragali: sweet in the mouth, warm in nature, enter spleen, lung meridian, there is tonification spleen soil, elevate a turnable ladder yang-energy, strengthening superficial resistance to stop perspiration, the effects such as holder skin ulcer granulation promoting, are mainly used in the weak anorexia and loose stool due to deficiency of both the splenic and pulmonary QI, shortness of breath and palpitation, the visceroptosis of sinking of QI of middle-JIAO, the metrorrhagia of QI failing to control blood is had blood in stool, chronic diarrhea proctoptosis; The spontaneous sweating of exterior deficiency, the cards such as insufficiency of vital energy and blood.
Radix seu Herba Gei aleppici: latin name Gei Herba, acrid in the mouth, hardship, property is flat, returns liver, spleen, lung meridian, has analgesia, blood pressure lowering, regulating menstruation, the effect of expelling wind and removing dampness, cures mainly hypertension, dizziness headache, menoxenia, lower abdominal pain, leucorrhea, infantile convulsion, lumbago, skelalgia of rheumatism; Carbuncle furuncle and phyma poison, the cards such as traumatic injury are controlled in external.
Semen Coicis: latin name Coicis Semen, sweet in the mouth, light, cold nature, enters lung, spleen, large intestine channel, has invigorating the spleen to arrest diarrhea, diuretic eliminating impediment, the effect of row's skin ulcer pus, cures mainly having loose bowels of wet tired lung stomach; Damp is invaded the hydrosarca of stain skin, dysuria; Damp and hot resistance in the numbness of QI and blood passes to and the scorchingly hot cards such as lung abscess in lung intestinal, acute appendicitis that pent up.
The Rhizoma Atractylodis Macrocephalae: sweet in the mouth, hardship, warm in nature, enter spleen, stomach warp, there is spleen reinforcing promoting the circulation of QI, dampness diuretic, strengthening superficial resistance to stop perspiration, the effect that activating the spleen is moisturized, is mainly used in the feeling of fullness diarrhoea due to dysfunction of the spleen in transportation, QI failing to transform into body fluid, phlegm retention edema; The vexed lazy speech of deficiency of QI in middle-JIAO, metrorrhagia and metrostaxis, proctoptosis with chronic dysentery; The cards such as solid in the playing of deficiency of the spleen causing weakness of QI, sweating due to debility spontaneous perspiration.
Herba Lysimachiae: sweet in the mouth, slightly stringy pulse, cold nature, enters liver, gallbladder, kidney, urinary bladder channel, has the effect of clearing away heat-damp and promoting diuresis, Tonglin Paishi, removing toxic substances and promoting subsidence of swelling, cures mainly liver and gall and urinary system calculus; Pyretic stranguria; Oedema due to nephritis; Jaundice due to damp-heat; Sore carbuncle; Venom; The cards such as traumatic injury, be usually used in acute and chronic infectious hepatitis, the treatment of gallbladder wing inflammation and hepatic secretion malfunction, total alkaloids in Herba Lysimachiae can significantly improve the content of total protein in serum (TP) and albumin (Alb), improve the content of fibrosis serum I FN-γ, reduce Serum ALT, have the effect of anti-hepatic fibrosis, its hepatoprotective effect is the mechanism of action of its fibrosis.
Herba Ecliptae: sweet in the mouth, acid, cold in nature, return liver, kidney channel, play liver and kidney tonifying, the effect of cooling blood for hemostasis, for having a dizzy spell due to the hepatic and renal YIN deficiency, blurring of vision, soreness of the waist and knees; Be suitable for the deficiency of YIN and have hot person, be used for the treatment of the haematemesis of accumulated heat in stomach, the symptoms such as the hemoptysis of injury of blood vessel of the lung by heat, Herba Ecliptae has inhibitory action to staphylococcus aureus, Bacillus typhi, Song's Shigella flexneri, bacillus pyocyaneus, obviously enhancing non-specific immunity and cellular immune function.
Caulis Spatholobi: bitter in the mouth, sweet, warm in nature, enter liver, kidney channel, there is blood vessel dilating, enrich blood and invigorate blood circulation, regulating menstruation, the effect of relaxing muscles and tendons and activating QI and blood in the collateral, has obvious inhibitory action to platelet aggregation, promote animal kidney and the total phosphorus metabolism in uterus, be mainly used in treating the menoxenia that blood deficiency has silt, limbs pain is meciless, the symptoms such as soreness of the waist and knees, pain.
Radix Polygoni Multiflori: bitter in the mouth, sweet, puckery, slightly warm in nature, returns liver, kidney channel, has the effect of nourishing the blood and yin, loosening bowel to relieve constipation, cures mainly blood deficiency Light-headedness; Cardiopalmus; Insomnia; The soreness of the waist and knees of the hepatic and renal YIN deficiency; Early whitening of beard and hair; Tinnitus; Seminal emission; Dryness of the intestine constipation; Chronic malaria body is empty; Rubella pruritus; Carbuncle sore; Scrofula; The cards such as hemorrhoid.
Radix Inulae: latin name Radix Inulae, acrid in the mouth, hardship, warm in nature, return liver, spleen channel, there is invigorating the spleen and regulating the stomach, promoting the flow of QI for relieving the stagnancy, the effect that pain relieving is antiabortive, cures mainly the breast side of body, abdominal distention, vomiting dysentery, the breast side of body is dampened, and feels a pain in the chest when breathing and has a pain, the cards such as frequent fetal movement.
The Radix Paeoniae Alba: latin name Paeoniae RadixAlba, bitter in the mouth, acid, cool in nature; enter liver, spleen channel, there is nourishing blood to suppress the hyperactive liver, slow middle pain relieving; yin fluid astringing is received the effect of antiperspirant, cures mainly the breast abdomen pain over the hypochondriac region, dysentery stomachache; spontaneous sweating; fever due to yin deficiency, menoxenia, metrorrhagia; be with inferior card, the Radix Paeoniae Alba has good liver-protective effect.
Radix Et Caulis Acanthopanacis Senticosi: latin name Acanthopanacis Senticosi Radix et Rhizoma seu Caulis, acrid in the mouth, hardship, micro-sweet, warm in nature, enter spleen, kidney, heart channel, there is replenishing QI to invigorate the spleen, tonifying the kidney for tranquilization, the effect of expelling wind and removing dampness, soft for anemofrigid-damp arthralgia, lumbocrural pain, muscles and bones flaccidity, be slow in action, a little less than body weakness with emaciation, traumatic injury, fracture, edema, beriberi, the uncontrolled urination card such as itch.
Semen Raphani: property is flat, and acrid in the mouth, sweet, returns lung, spleen, stomach warp, has the de-swelling of helping digestion, the effect of lowering the adverse-rising QI to resolve phlegm, cures mainly retention of food and drink, abdominal distention, constipation, stagnant dysentery, expectorant and stops up the card such as breath with cough.
Fructus Mori: sweet in the mouth, acid, cold in nature, GUIXIN, liver, kidney channel, have the YIN nourishing of enriching blood, the effect of promoting the production of body fluid and moisturizing.For vertigo and tinnitus, palpitation and insomnia, early whitening of beard and hair, Tianjin wound is thirsty, and interior-heat is quenched one's thirst, blood deficiency and constipation.Tonifying liver, kidney tonifying, relieves dizziness, high fever, infantile convulsions, epilepsy, etc., and grows liquid.Control hepatic and renal YIN deficiency, quench one's thirst, constipation, order is dark, tinnitus, scrofula, the cards such as articular instability.
Colla cornus cervi: latin name cervi cornus colla, sweet in the mouth, salty, warm in nature, return kidney, Liver Channel, have and mend warming the liver kidney, the effect of beneficial intensive culture blood, the waist knee joint acid curing mainly due to deficiency of the liver and kindey is cold, impotence and seminal emission, metrostaxis, the cards such as hematuria of having blood in stool.
Radix Salviae Miltiorrhizae: latin name Salviae Miltiorrhizae Radix et Rhizoma, bitter in the mouth, cold nature, enter the heart, Liver Channel, there is promoting blood flow to regulate menstruation, stasis-dispelling and pain-killing, removing heat from blood eliminating carbuncle, the relieving restlessness that clears away heart-fire, the effect of nourishing blood to tranquillize the mind, for menoxenia, amenorrhea dysmenorrhea, lump in the abdomen, breast ventral spine pain, pyretic arthralgia pain, skin infection swells and ache, dysphoria and insomnia; Hepatosplenomegaly, the cards such as angina pectoris.
Herba Verbenae: latin name Verbenae Herba, bitter in the mouth, cool in nature, return liver, spleen channel, there is promoting blood circulation to remove blood stasis, preventing the attack (or recurrence) of malaria, removing toxic substances, the effect of inducing diuresis to remove edema, cures mainly the cards such as lump in the abdomen, amenorrhea dysmenorrhea, malaria, sore throat, carbuncle, edema, pyretic stranguria.
Arillus Longan: sweet in the mouth, light, property is flat, attaches to the lung and stomach meridians, and has nourishing the lung to arrest cough, and the effect of relieving constipation, cures mainly xeropulmonary cough, throat aphonia, the cards such as constipation.
Radix Rehmanniae Preparata: sweet in the mouth, slightly warm in nature, enters liver, kidney channel, has the YIN nourishing of enriching blood, and beneficial essence is filled out the effect of marrow, cures mainly blood deficiency and yellow complexion; Dizzy, cardiopalmus, insomnia, menoxenia, collapses more than; Hepatic and renal YIN deficiency, night sweat, sufficient knee joint pain, soreness of the waist and knees, Hiccough and deaf, the head is dim-sighted; Seminal emission sexual impotence; Infertility; Menoxenia; Metrostaxis; Early whitening of beard and hair; Quench one's thirst; Constipation; The cards such as dyspnea with rapid and short breath of suffering from a deficiency of the kidney.
Caulis Gneti: bitter in the mouth, slightly warm in nature, has expelling wind and removing dampness, eliminating stasis to stop pain, the effect of preventing phlegm from forming and stopping coughing, cures mainly rheumatic arthralgia, lumbago, treating swelling and pain by traumatic injury, the fracture injury of tendon and muscle, ulcer haemorrhage, chronic tracheitis, the cards such as venom.
Fructus Choerospondiatis: sweet in the mouth, acid, property is flat, has promoting flow of QI and blood, tranquilizing by nourishing the heart, the effect of removing food stagnancy removing toxic substances, cures mainly qi depression to blood stasis, chest pain, shortness of breath and palpitation, neurasthenia, insomnia, bronchitis, dyspepsia abdominal distention, the cards such as diarrhoea.
Semen Juglandis: sweet in the mouth, warm in nature, enter kidney, lung, large intestine channel, there is the kidney invigorating and essence nourishing, warming the lung Dingchuan, the effect of loosening bowel to relieve constipation, lumbago lower limb for kidney qi virtual loss is soft, dizzy weak, frequent micturition seminal emission, quenches one's thirst, the cough with asthma of deficiency of both the lung and kidney, few and the dryness of the intestine constipation that causes in old people's deficiency of vital energy and anemia in puerperal Tianjin, traumatic injury, the cards such as skin infection carbuncle.
Pulvis ferri (ferrosic oxide): be recorded in < < herbal classic > >, chemical composition master is containing ferroso-ferric oxide or name magnetic oxide.Different name has: Pulvis Ferri (Ferrosic Oxide) (< < Plain Questions > >), ferrum liquid (< < does not record > >), ferrum dung (< < prescriptions worth thousand gold > >), iron filings (< < Tang materia medica > >), the ornamental work of iron (< < Bencao Tujing > >), ferrum moth (< < detailed outline > >).Its source is red red for the pig iron is calcined to, and is hammered into shape the iron filings that fall during outer oxide.Its concocting method is: get the pulvis ferri (ferrosic oxide) of laying while forging iron, remove its coal soil impurity, clean, dry.Pulvis ferri (ferrosic oxide) nature and flavor are pungent, cool, sweet, nontoxic, have the functions such as checking hyperfunction of the liver for relieving convulsion, control demented, febrile delirium, cardiopalmus, easily frightened susceptible to get angry and sore swollen toxin.
It is provided by the invention that to be used for the treatment of the nourish one's nature Chinese medicine of anemia of juvenile camp be peroral dosage form, can according to conventional preparation method, be prepared into any regular dosage forms such as tablet, electuary, capsule, pill, granule, effervescent, oral liquid, syrup, preferably be prepared into effervescent.
The present invention also provides a kind of nourish one's nature Chinese medicine effervescent of anemia of juvenile camp that is used for the treatment of, it comprises that Chinese medicine recited above is as effervescent major ingredient and effervescent adjuvant, the weight portion of effervescent major ingredient and effervescent adjuvant is respectively effervescent major ingredient 200 weight portion~300 weight portions, effervescent adjuvant 50 weight portion~400 weight portions, preferred effervescent major ingredient 300 weight portions, effervescent adjuvant 200 weight portions.
Described effervescent adjuvant comprises carbon dioxide source, acid source, disintegrating agent and filler.
Acid source is selected from: any one or more mixing in citric acid, tartaric acid, fumaric acid, adipic acid, malic acid, water-soluble amino acid, boric acid, citric acid.
Carbon dioxide source is selected from: any one or more mixing in calcium bicarbonate, sodium carbonate, sodium bicarbonate, sodium bitartrate, potassium carbonate, potassium bicarbonate.
Filler is selected from any one or more mixing in Polyethylene Glycol, erythritol, sorbitol, fructose, D-ribose acid-gamma lactone, arabitol, trehalose, D-ribose, low melting-point agarose, Lac, xylitol, Raffinose, glucose, isomalt, lactose, maltose.
Disintegrating agent is selected from starch, cellulose, arabic gum, dextran, chitin, sesbania gum, carrageenan, Ficus elastica, Furcellaran, tragakanta, carrageenin, tamarind gum, pectin, xanthan gum, alginic acid, dextrin, cyclodextrin, agar, any one or more mixing in lactose, described starch is as pregelatinized Starch, modified starch, hydroxypropyl starch, carboxymethyl starch, described cellulose is as methylcellulose, microcrystalline Cellulose, sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose, the fine plain sodium of cross-linked carboxymethyl, hydroxyethylmethyl-cellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose.
Disintegrating agent in effervescent adjuvant: acid source: carbon dioxide source: the ratio of the weight of filler is 0.5~0.8: 0.4~0.6: 0.3~0.6: 0.4~0.6.
The present invention also provides the preparation method of above-mentioned Chinese medicine effervescent, is specially:
The first step, the extraction of above-mentioned Chinese medicine effervescent major ingredient;
Second step, the purification of extract;
The 3rd step, by the extract after second step purification and effervescent adjuvant mixing granulation, tabletting, obtains effervescent tablet.
The described first step is specially mixes each raw material medicaments in part by weight in described Chinese medicine, stir, add the water with respect to 6~8 times of mixture qualities, it is 2~3 that the hydrochloric acid that is 5% by volumetric concentration regulates the pH value of water, soak 1 hour~2 hours, decoct subsequently 3 hours~5 hours, decoction liquor is filtered, filtering residue adds the water with respect to 4~6 times of mixture qualities again, decoct 3 hours~5 hours, decoction liquor is filtered, decoction liquor is merged, by mass percentage concentration, be that 10% sodium hydroxide regulates pH value to 6~7, obtain extracting solution, the mastic that at 50 ℃ of extracting solution simmer down tos, relative density is 1.10~1.20, be cooled to room temperature, adding concentration is that 95% ethanol to alcohol content reaches 60%, 0 ℃ of cold preservation 12 hours, filter, filtrate decompression concentration and recovery ethanol, be concentrated into the mastic that at 50 ℃, relative density is 1.10~1.20.
Described second step is specially the thick paste that the first step is obtained and adds on the macroporous adsorptive resins of D101 type, first adopt the water of 1~2 times of column volume to rinse, adopting 3~5 times of ethanol elutions that column volume determining alcohol is 30%, adopt again the ethanol elution that 3~5 times of column volume determining alcohols are 70%, the ethanol elution that the ethanol elution that collection determining alcohol is 30% and determining alcohol are 70%, being evaporated to relative density at 50 ℃ is 1.10~1.20, add isopyknic water, 0 ℃ of cold preservation 12 hours, filter, filtrate is concentrated except desolventizing, pulverize, dry, obtain Chinese medicine composition and extract purified.
Below adopt embodiment to describe embodiments of the present invention in detail, to the present invention, how application technology means solve technical problem whereby, and the implementation procedure of reaching technique effect can fully understand and implement according to this.
Embodiment 1 Chinese medicine composition effervescent 1
By Radix Ginseng 65g, Radix Astragali 55g, Radix seu Herba Gei aleppici 50g, Semen Coicis 35g, Rhizoma Atractylodis Macrocephalae 35g, Herba Lysimachiae 25g, Herba Ecliptae 40g, Caulis Spatholobi 85g, Radix Polygoni Multiflori 65g, Radix Inulae 30g, Radix Paeoniae Alba 55g, Radix Et Caulis Acanthopanacis Senticosi 35g, Semen Raphani 30g, Fructus Mori 65g, Colla cornus cervi 75g, Radix Salviae Miltiorrhizae 35g, Herba Verbenae 35g, Arillus Longan 35g, Radix Rehmanniae Preparata 95g, Caulis Gneti 35g, Fructus Choerospondiatis 40g, Semen Juglandis 65g, pulvis ferri (ferrosic oxide) 50g mixes, stir, the water that adds 8kg, it is 3 that the hydrochloric acid that is 5% by volumetric concentration regulates the pH value of water, soak 2 hours, decoct subsequently 5 hours, decoction liquor is filtered, filtering residue adds the water of 5.5kg again, decoct 5 hours, decoction liquor is filtered, decoction liquor is merged, by mass percentage concentration, be that 10% sodium hydroxide regulates pH value to 7, obtain extracting solution, the mastic that at 50 ℃ of extracting solution simmer down tos, relative density is 1.20, be cooled to room temperature, adding concentration is that 95% ethanol to alcohol content reaches 60%, 0 ℃ of cold preservation 12 hours, filter, filtrate decompression concentration and recovery ethanol, being concentrated into the mastic that at 50 ℃, relative density is 1.20 adds the thick paste of acquisition on the macroporous adsorptive resins of D101 type, first adopt the water of 2 times of column volumes to rinse, adopting 5 times of ethanol elutions that column volume determining alcohol is 30%, adopt again the ethanol elution that 5 times of column volume determining alcohols are 70%, the ethanol elution that the ethanol elution that collection determining alcohol is 30% and determining alcohol are 70%, being evaporated to relative density at 50 ℃ is 1.20, add isopyknic water, 0 ℃ of cold preservation 12 hours, filter, filtrate is concentrated except desolventizing, pulverize, dry, obtain Chinese medicine composition and extract purified, get 300g and 60g starch, 50g citric acid, 40g sodium bicarbonate, 50g Polyethylene Glycol mixing granulation, tabletting, obtains effervescent tablet, every 1g.
Embodiment 2 Chinese medicine composition effervescents 2
By Radix Ginseng 70g, Radix Astragali 60g, Radix seu Herba Gei aleppici 55g, Semen Coicis 30 weight portions~35g, Rhizoma Atractylodis Macrocephalae 40g, Herba Lysimachiae 25g, Herba Ecliptae 40g, Caulis Spatholobi 90g, Radix Polygoni Multiflori 70g, Radix Inulae 30g, Radix Paeoniae Alba 60g, Radix Et Caulis Acanthopanacis Senticosi 35g, Semen Raphani 30g, Fructus Mori 70g, Colla cornus cervi 80g, Radix Salviae Miltiorrhizae 40g, Herba Verbenae 35g, Arillus Longan 40g, Radix Rehmanniae Preparata 100g, Caulis Gneti 35g, Fructus Choerospondiatis 40g, Semen Juglandis 70g, pulvis ferri (ferrosic oxide) 55g mixes, stir, the water that adds 8.3kg, it is 3 that the hydrochloric acid that is 5% by volumetric concentration regulates the pH value of water, soak 2 hours, decoct subsequently 5 hours, decoction liquor is filtered, filtering residue adds the water of 5.8kg again, decoct 5 hours, decoction liquor is filtered, decoction liquor is merged, by mass percentage concentration, be that 10% sodium hydroxide regulates pH value to 7, obtain extracting solution, the mastic that at 50 ℃ of extracting solution simmer down tos, relative density is 1.20, be cooled to room temperature, adding concentration is that 95% ethanol to alcohol content reaches 60%, 0 ℃ of cold preservation 12 hours, filter, filtrate decompression concentration and recovery ethanol, being concentrated into the mastic that at 50 ℃, relative density is 1.20 adds the thick paste of acquisition on the macroporous adsorptive resins of D101 type, first adopt the water of 2 times of column volumes to rinse, adopting 5 times of ethanol elutions that column volume determining alcohol is 30%, adopt again the ethanol elution that 5 times of column volume determining alcohols are 70%, the ethanol elution that the ethanol elution that collection determining alcohol is 30% and determining alcohol are 70%, being evaporated to relative density at 50 ℃ is 1.20, add isopyknic water, 0 ℃ of cold preservation 12 hours, filter, filtrate is concentrated except desolventizing, pulverize, dry, obtain Chinese medicine composition and extract purified, get 300g and 60g starch, 50g citric acid, 40g sodium bicarbonate, 50g Polyethylene Glycol mixing granulation, tabletting, obtains effervescent tablet, every 1g.
Embodiment 3 Chinese medicine composition effervescents 3
By Radix Ginseng 65g, Radix Astragali 55g, Radix seu Herba Gei aleppici 50g, Semen Coicis 30g, Rhizoma Atractylodis Macrocephalae 35g, Herba Lysimachiae 20g, Herba Ecliptae 35g, Caulis Spatholobi 85g, Radix Polygoni Multiflori 65g, Radix Inulae 25g, Radix Paeoniae Alba 55g, Radix Et Caulis Acanthopanacis Senticosi 30g, Semen Raphani 25g, Fructus Mori 65g, Colla cornus cervi 75g, Radix Salviae Miltiorrhizae 35g, Herba Verbenae 30g, Arillus Longan 35g, Radix Rehmanniae Preparata 95g, Caulis Gneti 30g, Fructus Choerospondiatis 35g, Semen Juglandis 65g, pulvis ferri (ferrosic oxide) 50g mixes, stir, the water that adds 8kg, it is 3 that the hydrochloric acid that is 5% by volumetric concentration regulates the pH value of water, soak 2 hours, decoct subsequently 5 hours, decoction liquor is filtered, filtering residue adds the water of 5.5kg again, decoct 5 hours, decoction liquor is filtered, decoction liquor is merged, by mass percentage concentration, be that 10% sodium hydroxide regulates pH value to 7, obtain extracting solution, the mastic that at 50 ℃ of extracting solution simmer down tos, relative density is 1.20, be cooled to room temperature, adding concentration is that 95% ethanol to alcohol content reaches 60%, 0 ℃ of cold preservation 12 hours, filter, filtrate decompression concentration and recovery ethanol, being concentrated into the mastic that at 50 ℃, relative density is 1.20 adds the thick paste of acquisition on the macroporous adsorptive resins of D101 type, first adopt the water of 2 times of column volumes to rinse, adopting 5 times of ethanol elutions that column volume determining alcohol is 30%, adopt again the ethanol elution that 5 times of column volume determining alcohols are 70%, the ethanol elution that the ethanol elution that collection determining alcohol is 30% and determining alcohol are 70%, being evaporated to relative density at 50 ℃ is 1.20, add isopyknic water, 0 ℃ of cold preservation 12 hours, filter, filtrate is concentrated except desolventizing, pulverize, dry, obtain Chinese medicine composition and extract purified, get 300g and 60g starch, 50g citric acid, 40g sodium bicarbonate, 50g Polyethylene Glycol mixing granulation, tabletting, obtains effervescent tablet, every 1g.
The pharmacology test of embodiment 4 Chinese medicine compositions
Acute toxicity test
Choose 30 kunming mices, by Qingdao City's laboratory animal and zoopery center, provided, be divided into three groups, be respectively 1 group of Chinese medicine composition, 3 groups of 2 groups of Chinese medicine compositions and Chinese medicine compositions, the Chinese medicine effervescent tablet of oral administration gavage embodiments of the invention 1 to embodiment 3 preparation, Chinese medicine effervescent tablet is dissolved in to gavage in distilled water, under 750g crude drug/kg dosage, after administration, mice occurs that light activity reduces, about 1 hour, recover normal, after administration, Continuous Observation is 7 days, none animal dead, its overall health of patients, diet, take the photograph water, urine and body weight gain are all normal, experimental result shows: the maximum dosage-feeding of mice oral administration gavage Chinese medicine composition of the present invention is 750g crude drug/kg/d (LD50>750g crude drug/kg).Quantity every day of Chinese medicine composition of the present invention is 0.1g crude drug/kg/d; Press weighing machine, the dosis tolerata of mouse stomach Chinese medicine composition of the present invention is clinical patient 7500 times.Point out this medicine acute toxicity extremely low, clinical drug safety.
Long term toxicity test
Select 30 SD rats, by Qingdao City's laboratory animal and zoopery center, provided, be divided into three groups, give the Chinese medicine composition of embodiments of the invention 1 preparation of variable concentrations (54.0,27.0,9.0g crude drug/kg), Chinese medicine composition is dissolved in to gavage in distilled water, every day gavage once, continuous 90 days, after last administration, 24 hours each groups are lived and are killed 1/2 animal (male and female half and half), and all the other 1/2 animals continue observation and live and kill after 2 weeks.Duration of test is observed outward appearance, general behavior, food ration, the body weight change of animal, and after administration, the index checkings such as hematology's (RBC, HB, reticulocyte, PLT, CT, WBC and classification) and blood biochemical (AST, ALT, ALP, Glu, BUN, Crea, TP, T.BIL, ALB, CHOL), urine biochemistry, organ coefficient, histopathology are carried out in 90 days and drug withdrawal for 2 weeks.Result of the test shows: Chinese medicine preparation of the present invention is good at high, medium and low dosage treated animal general state, and outward appearance sign, behavioral activity, food-intake and body weight gain are all without ANOMALOUS VARIATIONS; Three dosage groups and matched group hematological examination, blood biochemical are learned, urine biochemical analysis is all in normal range, between group without significant difference; Each is organized main organs histopathological examination and shows no obvious abnormalities.These parameters drug withdrawal also has no change after 2 weeks.This test dosage is respectively 540,270,90 times of clinical medicine dose, according to result of the test Chinese medicine preparation of the present invention, in high, medium and low three dosage (54.0,27.0,9.0g crude drug/kg) administration in continuous 90 days, rat is had no significant effect, without clear and definite toxicity target organ and sensitive indicator, convalescent period observation also has no retardance toxic reaction, points out the dosage safety of Chinese medicine preparation clinical practice of the present invention higher.
Embodiment 5 zooperies
Experimental apparatus
Atomic absorption spectrophotometer (Spect r AA-20 type), F4000 spectrofluorophotometer (FDAC), Hb1002 hemoglobin determinator (Shanghai Yue Hai Huimin scientific instrument company limited), F T-630 γ-enumerator (Beijing nuclear medicine instrument plant); 3700 full-automatic blood counting instruments (U.S. Abbott).
Reagent
The Chinese medicine effervescent tablet of the embodiment of the present invention 1 preparation, the potassium ferricyanide, ethyl acetate, kieselguhr, sodium chloride (Guangzhou chemical reagent work); Acetic acid heparin (Tianjin Hao Nian medical product company limited); Serum ferritin and total iron binding capacity test kit (Beijing Zhong Sheng Bioisystech Co., Ltd); Low ferrum feedstuff (Shandong Center for Disease Control & Prevention's laboratory).
Laboratory animal
80 SPF level SD rats, body weight 70~90g,You Qingdao City laboratory animals and zoopery center provide.
Set up anemia model
80 SD rats are placed in to laboratory environment to be adapted to after 5d, 20 give normal rat normal feedstuff and normal drinking water, and as blank group, all the other 60 give low ferrum feedstuff and drink deionized water, after 20d, adopt tail blood examination and survey hemoglobin (Hb), by Hb lower than 100gL -1rat as nutritional anemia animal pattern.
Before modeling, the initial body weight there was no significant difference of the low ferrum feedstuff of feed conventional feed group and feed group.After modeling 7d, model group Mouse Weight, significantly lower than blank group, illustrates that model group mouse growth will be slower than normal group mice.In modeling process, observe, with blank group ratio, model group mice starts to occur palor at test 10d, and fur is coarse, sparse, and along with test period prolongation above-mentioned symptom is more obvious, health is become thin, and hair color tarnishes, and ear, claw all occur obviously pale, performance asthenia, movable minimizing, bradykinesia, likes the group of shortening into.Its performance reduces with ferrum, and anemia increases the weight of gradually, causes neural relevant with digestive functional disturbance.
Experimental technique and observation index
Anemia in Rats is divided into model group (20), positive controls (20) and Chinese drug-treated group (20) at random.Each treated animal of experimental session continues the low ferrum feedstuff of feed, and (gavage gives 10mLkg with drinking deionized water -1deionized water), Chinese drug-treated group gives the Chinese medicine effervescent tablet of the embodiment of the present invention 1 preparation, is dissolved in distilled water gavage mice, 2.0g (crude drug) kg -1(be equivalent to human body recommended amounts every day 20 times), and positive controls separately gives ferrous sulfate 2.0mgkg -1, continuous 30d, iron content in free protoporphyrin (F EP), liver, spleen tissue in Measuring hemoglobin (Hb), RBC number (RBC), packed cell volume (HC T), erythrocyte.
Biochemical Indexes
Hemoglobin (Hb)
Adopt HemoCue Measuring hemoglobin content, with 10 μ l quantitative capillary tubes, get rat tail blood, put into the plastic tube that fills 2.5ml high-potassium ferricyanide reagent, fully vibration, make the complete stripping of blood, lucifuge is placed after 15min, measures, simultaneously Measuring hemoglobin standard and primary standard substance with Hemoglobin Meter.
Packed cell volume (HC T)
With 9 μ l quantitative capillary tubes, get blood, one end is sealed with plasticine, adopt hematocrit measurement instrument to measure, reading result after 2min is measured basis reference blood sample simultaneously.
RBC number (RBC)
With full-automatic blood counting instrument, measure.
Free erythrocyte protoporphyrin (F EP)
On special filter paper, deposit droplets of whole blood in 4 ℃ of refrigerators standby (time is no more than 2 months) after to be dried.During mensuration, with card punch, will squeeze in teat glass with the filter paper of drop of blood, add 2% tripolite solution, put into 4 ℃ of refrigerator overnight eluting, add ethyl acetate: the extraction of glacial acetic acid (4:1) mixed liquor, centrifugal 10min, gets supernatant and adds 0.5mol/L hydrochloric acid, vibrate centrifugal, take off a layer liquid fluorescent spectrophotometer assay.
Iron content in liver, spleen tissue
After off-test, get about 0.2g tissue and put into the teat glass through hydrochloric acid dry cleansing, add nitric acid: perchloric acid (4:1) mixed acid 2ml, after digestion, with deionized water, be settled to 5ml or 10ml, adopt flame atomization to measure iron content in tissue, each mensuration with Hepar Bovis seu Bubali powder (NBS1577a of NBS) as Quality Control material.
Statistical procedures
Adopt SPSS10.0 statistical software to carry out variance analysis to experimental data, result with
Figure BDA0000400542930000161
represent.
Result
The impact of Chinese medicine effervescent tablet on nutritional anemia rat hemoglobin, the results are shown in Table 1.
Table 1 changes before and after respectively organizing the experiment of nutritional anemia rat hemoglobin
With model group comparison: *p<0.01; With the comparison of blank group: #p<0.01
As can be seen from Table 1, before test, model group, positive controls, the hemoglobin of Chinese drug-treated group rat and blank group have significant difference, P<0.01, after experiment, the Hemoglobin Value of Chinese drug-treated group is significantly higher than before experiment, and higher than positive controls and model group, shows that Chinese medicine effervescent tablet can significantly promote the Hemoglobin Value of rat.
The impact of Chinese medicine effervescent tablet on nutritional anemia rat RBC, HCT, the results are shown in Table 2.
Table 2 changes before and after respectively organizing nutritional anemia rat RBC, HCT experiment
Figure BDA0000400542930000172
With model group comparison: *p<0.01; With the comparison of blank group: #p<0.01
As can be seen from Table 2, before test, model group, positive controls, the RBC number of Chinese drug-treated group and packed cell volume value and blank group have significant difference, P<0.01, after experiment, the RBC number of Chinese drug-treated group and packed cell volume value are significantly higher than before experiment, and higher than positive controls and model group, show that Chinese medicine effervescent tablet has remarkable facilitation to the RBC number of rat and packed cell volume value.
The impact of Chinese medicine effervescent tablet on nutritional anemia rat F EP, the results are shown in Table 3.
Table 3 changes before and after respectively organizing nutritional anemia rat F EP experiment
Figure BDA0000400542930000173
With model group comparison: *p<0.01; With the comparison of blank group: #p<0.01
As can be seen from Table 3, before test, model group, positive controls, free erythrocyte protoporphyrin content and the blank group of Chinese drug-treated group have significant difference, P<0.01, after experiment, the free erythrocyte protoporphyrin content of Chinese drug-treated group is significantly higher than before experiment, and higher than positive controls and model group, shows that Chinese medicine effervescent tablet has remarkable reducing effect to the free erythrocyte protoporphyrin content of rat.
The impact of Chinese medicine effervescent tablet on iron content in nutritional anemia rat liver and spleen tissue, the results are shown in Table 4 and table 5.
Table 4 is respectively organized iron content in liver organization
Figure BDA0000400542930000182
Compare with model group, *p<0.05
Table 5 is respectively organized iron content in spleen tissue
Compare with model group, *p<0.05
From table 4 and table 5, can find out, before experiment, respectively organize liver and the spleen weight difference not statistically significant (P>0.05) of rat, after experiment, in the rat liver of Chinese drug-treated group and spleen, iron content and total iron content are all significantly higher than model group, and higher than positive controls.
From data above, Chinese medicine effervescent tablet provided by the invention has the effect that improves rat nutritional anemia.
Embodiment 9 clinical datas
The child who selects 110 examples to suffer from nutritional anemia carries out this observation of curative effect.Be divided at random treatment group 70 examples, male 38 examples wherein, female's 32 examples; At minimum 1 month of age, maximum 14 years old, average 5 years old 3 months, matched group was totally 40 examples.Male's 19 examples wherein, women's 21 examples, 2.5 months of age minimum, maximum 12 years old, average 5 years old 3 months, the infant course of disease 10 days to 6 months.Its clinical manifestation can have dizziness, easily tired, mucocutaneous just pale, the most obvious with lip, oral mucosa, nail matrix and palm.Loss of appetite, be prone to stomatitis, distraction, hypomnesis, easily irritated, easily suffer from respiratory tract infection.Lab testing is microcytic hypochromic anemia.All infants are all got rid of serious disease and the psychotics such as lead poisoning, cardiovascular and cerebrovascular vessel, Liver and kidney, digestive tract.Two groups of patients' mean age, M-F, the clinical data aspect no significant differences such as the state of an illness, have comparability.
Therapeutic Method
Take merely Ferroids (ferrous sulfate controlled release tablet, Guangzhou Mai Te Xinghua pharmaceutical factory produces, 0.2g/ time, divide 1~2 time oral, serve on 2 weeks.After, Anemia normal until Hemoglobin Value corrected, by 2mg/kg, weekly 1 time oral, serve on 4 weeks.Coordinate folic acid, vitamin C, pepsin mixture etc. simultaneously.Have and infect symptom and add anti-infective, the person's anthelmintic that has parasitosis.
The Chinese medicine effervescent tablet of the oral embodiment of the present invention 1 preparation for the treatment of group, respectively take 1 time every day sooner or later, and each 1, serve on 1 week, treat Anemia correction, after hemoglobin is normal, following the service 4 weeks, consolidates curative effect, and 2 years old following child can be reduced by half and be taken.
Criterion of therapeutical effect
Cure: clinical symptoms is obviously improved.Male: Hb>120g/L, RBC>4 * 10 12/ L.Women: Hb>110g/L, RBC>3.5 * 10 12/ L.Take a turn for the better: 20g/L at least rises before within 8 weeks, interior Hb treats.Invalid: not reach above-mentioned standard.
Statistical procedures
Adopt SPSS10.0 statistical software to carry out variance analysis to experimental data, result with
Figure BDA0000400542930000191
represent.
Two groups of therapeutic effect comparisons, the results are shown in Table 6.
Table 6 liang group therapeutic effect comparison
Group Number of cases Cure Take a turn for the better Invalid Effective percentage (%)
Treatment group 60 51 9 0 100%
Matched group 40 12 13 15 62.5%
As can be seen from Table 6, adopt Chinese medicine effervescent tablet of the present invention to there is significant treatment at treatment child nutrition ischemia and maintain effect.
Two groups of anemia experimental index are observed, and the results are shown in Table 7.
A table 7 liang group anemia experimental index is observed
Figure BDA0000400542930000201
Relatively front with treatment: *p<0.05
As can be seen from Table 7, adopt Chinese medicine effervescent tablet of the present invention can significantly improve lab index RBC, Hb, the HCT of anemia.
The comparison of two groups of infant untoward reaction situation occurreds, the results are shown in Table 8.
Table 8 liang group infant untoward reaction situation occurred comparison
Group Number of cases Inappetence Nausea and vomiting Epigastric discomfort Diarrhoea Fraction defective
Treatment group 70 0 1 2 1 5.7%
Matched group 40 3 2 4 3 30%
As can be seen from Table 8, Chinese medicine effervescent tablet untoward reaction provided by the invention is few, is a kind of medicine of good treatment anemia.
All above-mentioned these intellectual properties of primary enforcement, do not set restriction this new product of other forms of enforcement and/or new method.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar implementation status.But all modifications or transformation belong to the right of reservation based on new product of the present invention.
The above, be only preferred embodiment of the present invention, is not the present invention to be done to the restriction of other form, and any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the equivalent embodiment of equivalent variations.But every technical solution of the present invention content that do not depart from, any simple modification, equivalent variations and the remodeling above embodiment done according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.

Claims (10)

1. one kind is used for the treatment of the nourish one's nature Chinese medicine effervescent of anemia of juvenile camp, it is characterized in that: comprise that Chinese medicine composition is as effervescent major ingredient and effervescent adjuvant, the weight portion of effervescent major ingredient and effervescent adjuvant is respectively effervescent major ingredient 200 weight portion~300 weight portions, effervescent adjuvant 50 weight portion~400 weight portions.
2. Chinese medicine effervescent as claimed in claim 1, is characterized in that: the crude drug component of described Chinese medicine composition comprises Radix Ginseng, the Radix Astragali, Radix seu Herba Gei aleppici, Semen Coicis, the Rhizoma Atractylodis Macrocephalae, Herba Lysimachiae, Herba Ecliptae, Caulis Spatholobi, Radix Polygoni Multiflori, Radix Inulae, the Radix Paeoniae Alba, Radix Et Caulis Acanthopanacis Senticosi, Semen Raphani, Fructus Mori, Colla cornus cervi, Radix Salviae Miltiorrhizae, Herba Verbenae, Arillus Longan, Radix Rehmanniae Preparata, Caulis Gneti, Fructus Choerospondiatis, Semen Juglandis and pulvis ferri (ferrosic oxide).
3. Chinese medicine effervescent as claimed in claim 1 or 2, is characterized in that: in described Chinese medicine, the weight of each crude drug is respectively that people joins 60 weight portion~70 weight portions, the Radix Astragali 50 weight portion~60 weight portions, Radix seu Herba Gei aleppici 45 weight portion~55 weight portions, Semen Coicis 30 weight portion~40 weight portions, the Rhizoma Atractylodis Macrocephalae 30 weight portion~40 weight portions, Herba Lysimachiae 20 weight portion~30 weight portions, Herba Ecliptae 35 weight portion~45 weight portions, Caulis Spatholobi 80 weight portion~90 weight portions, Radix Polygoni Multiflori 60 weight portion~70 weight portions, Radix Inulae 25 weight portion~35 weight portions, the Radix Paeoniae Alba 50 weight portion~60 weight portions, Radix Et Caulis Acanthopanacis Senticosi 30 weight portion~40 weight portions, Semen Raphani 25 weight portion~35 weight portions, Fructus Mori 60 weight portion~70 weight portions, Colla cornus cervi 70 weight portion~80 weight portions, Radix Salviae Miltiorrhizae 30 weight portion~40 weight portions, Herba Verbenae 30 weight portion~40 weight portions, Arillus Longan 30 weight portion~40 weight portions, Radix Rehmanniae Preparata 90 weight portion~100 weight portions, Caulis Gneti 30 weight portion~40 weight portions, Fructus Choerospondiatis 35 weight portion~45 weight portions, Semen Juglandis 60 weight portion~70 weight portions, pulvis ferri (ferrosic oxide) 45 weight portion~55 weight portions.
4. the Chinese medicine effervescent as described in claims 1 to 3, it is characterized in that: in described Chinese medicine composition, the weight of each crude drug is respectively that people joins 65 weight portions, the Radix Astragali 55 weight portions, Radix seu Herba Gei aleppici 50 weight portions, Semen Coicis 35 weight portions, the Rhizoma Atractylodis Macrocephalae 35 weight portions, Herba Lysimachiae 25 weight portions, Herba Ecliptae 40 weight portions, Caulis Spatholobi 85 weight portions, Radix Polygoni Multiflori 65 weight portions, Radix Inulae 30 weight portions, the Radix Paeoniae Alba 55 weight portions, Radix Et Caulis Acanthopanacis Senticosi 35 weight portions, Semen Raphani 30 weight portions, Fructus Mori 65 weight portions, Colla cornus cervi 75 weight portions, Radix Salviae Miltiorrhizae 35 weight portions, Herba Verbenae 35 weight portions, Arillus Longan 35 weight portions, Radix Rehmanniae Preparata 95 weight portions, Caulis Gneti 35 weight portions, Fructus Choerospondiatis 40 weight portions, Semen Juglandis 65 weight portions, pulvis ferri (ferrosic oxide) 50 weight portions.
5. the Chinese medicine effervescent as described in claim 1 to 4, is characterized in that: described effervescent adjuvant comprises carbon dioxide source, acid source, disintegrating agent and filler.
6. the Chinese medicine effervescent as described in claim 1 to 5, is characterized in that: disintegrating agent in effervescent adjuvant: acid source: the ratio of the weight of carbon dioxide source is 0.5~0.8: 0.4~0.6: 0.3~0.6: 0.4~0.6.
7. the preparation method of Chinese medicine effervescent described in claim 1 to 6, is characterized in that:
The first step, the extraction of described Chinese medicine composition;
Second step, the purification of the extract that the first step obtains;
The 3rd step, by the extract after second step purification and effervescent adjuvant mixing granulation, tabletting, obtains effervescent tablet.
8. the preparation method of Chinese medicine effervescent as claimed in claim 7, it is characterized in that: the described first step is specially mixes each raw material medicaments in part by weight in described Chinese medicine composition, stir, add the water with respect to 6~8 times of mixture qualities, it is 2~3 that the hydrochloric acid that is 5% by volumetric concentration regulates the pH value of water, soak 1 hour~2 hours, decoct subsequently 3 hours~5 hours, decoction liquor is filtered, filtering residue adds the water with respect to 4~6 times of mixture qualities again, decoct 3 hours~5 hours, decoction liquor is filtered, decoction liquor is merged, by mass percentage concentration, be that 10% sodium hydroxide regulates pH value to 6~7, obtain extracting solution, the mastic that at 50 ℃ of extracting solution simmer down tos, relative density is 1.10~1.20, be cooled to room temperature, adding concentration is that 95% ethanol to alcohol content reaches 60%, 0 ℃ of cold preservation 12 hours, filter, filtrate decompression concentration and recovery ethanol, be concentrated into the mastic that at 50 ℃, relative density is 1.10~1.20.
9. the preparation method of Chinese medicine effervescent as claimed in claim 7 or 8, it is characterized in that: described second step is specially the thick paste that the first step is obtained and adds on the macroporous adsorptive resins of D101 type, first adopt the water of 1~2 times of column volume to rinse, adopting 3~5 times of ethanol elutions that column volume determining alcohol is 30%, adopt again the ethanol elution that 3~5 times of column volume determining alcohols are 70%, the ethanol elution that the ethanol elution that collection determining alcohol is 30% and determining alcohol are 70%, being evaporated to relative density at 50 ℃ is 1.10~1.20, add isopyknic water, 0 ℃ of cold preservation 12 hours, filter, filtrate is concentrated except desolventizing, pulverize, dry, obtain Chinese medicine composition and extract purified.
10. be used for the treatment of the nourish one's nature Chinese medicine composition of anemia of juvenile camp, it is characterized in that: the crude drug component of described Chinese medicine composition comprises Radix Ginseng, the Radix Astragali, Radix seu Herba Gei aleppici, Semen Coicis, the Rhizoma Atractylodis Macrocephalae, Herba Lysimachiae, Herba Ecliptae, Caulis Spatholobi, Radix Polygoni Multiflori, Radix Inulae, the Radix Paeoniae Alba, Radix Et Caulis Acanthopanacis Senticosi, Semen Raphani, Fructus Mori, Colla cornus cervi, Radix Salviae Miltiorrhizae, Herba Verbenae, Arillus Longan, Radix Rehmanniae Preparata, Caulis Gneti, Fructus Choerospondiatis, Semen Juglandis and pulvis ferri (ferrosic oxide).
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CN103989656A (en) * 2014-04-22 2014-08-20 安徽省太湖山中药饮片有限公司 Ilex kudingcha and longan effervescent tablet and preparation method thereof
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